TransCon Growth Hormone
Ascendis Pharma has successfully completed Phase 2 studies of TransCon Growth Hormone* in both children and adults with Growth Hormone Deficiency (GHD) and has initiated a Phase 3 study of TransCon Growth Hormone in children with GHD. We believe TransCon Growth Hormone has the potential to be a best-in-class long-acting human growth hormone therapy.
For the past 25 years, children and adults that fail to produce adequate amounts of endogenous growth hormone have been treated using daily injections of recombinant human growth hormone, or hGH, which is identical to the growth hormone produced by the body. While the dose of daily hGH has been optimized for safety and efficacy, the administrative burden of daily injections causes two out of three patients to miss more than one injection per week. This poor compliance is associated with sub-optimal treatment outcomes.
TransCon Growth Hormone aims to provide patients affected by GHD with a replacement therapy and an easy-to-remember once-weekly administration. TransCon Growth Hormone is the only late-stage long-acting growth hormone program in development that releases native growth hormone into the bloodstream, delivering native growth hormone at the same peak and total exposure levels as daily growth hormone injections. This preserves the same mode of action and distribution in the body as both daily and endogenous growth hormone.
Ascendis Pharma is also developing a state-of-the-art pen device for administration of TransCon Growth Hormone to enable a single low-volume injection with 30 gauge or finer needles comparable to those used with current daily growth hormone therapies. For convenience, TransCon Growth Hormone is designed to be stable for storage at room temperature.
TransCon Growth Hormone is designed to enable clinicians to treat their patients with the same optimal treatment regimen they use in their current clinical practice while offering an improved once-weekly dosing regimen that may improve compliance and treatment outcomes.
*TransCon Growth Hormone is owned by Ascendis Pharma Endocrinology Division A/S; a company in the Ascendis Pharma Group
Positive Phase 2 Data
Our once-weekly TransCon Growth Hormone product candidate has demonstrated comparable efficacy and safety to daily growth hormone. Review Phase 2 Data
Phase 3 heiGHt Trial
We have initiated the heiGHt Trial, our Phase 3 clinical trial for TransCon Growth Hormone in children with GHD. Healthcare professionals interested in more information about the heiGHt trial can visit: www.heighttrial.com.
Growth Hormone Deficiency
Children with GHD are characterized by short stature, metabolic abnormalities, cognitive deficiencies and poor quality of life. GHD in adults is associated with premature mortality, increased adiposity, or fat mass, as well as psychiatric-cognitive, cardiovascular, muscular, metabolic and skeletal abnormalities.